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usp-2073-dissolution-of-multi-compartment-capsules
Dissolution and Disintegration Testing EMA Guideline on the Investigation of Bioequivalence—Dissolution CriteriaFDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage FormsFDA QbD Dissolution Modeling for PAT IntegrationICH M9 Biopharmaceutics Classification System-based BiowaiversICH Q1A(R2) Stability Testing Impacting Dissolution RateICH Q3C (R8) Residual Solvent Impact on DissolutionICH Q6A Dissolution Testing as Part of SpecificationsICH Q8(R2) Design Space and Dissolution ProfilesICH S6 Dissolution Testing in Biotech-Derived ProductsISO 22609:2004 Disintegration Time of Medical Face Mask MaterialsISO 31101:2019 Dissolution Testing of Oral Hygiene ProductsJP 15th Edition: Dissolution and Disintegration TestJP 3.09 Disintegration Test for Capsules and TabletsJP General Chapter 6.10 Dissolution Test for SuppositoriesPh. Eur. 2.9.1 Disintegration Test for Solid Dosage FormsPh. Eur. 2.9.29 Disintegration of Tablets for Veterinary UsePh. Eur. 2.9.3 Dissolution Testing of Oral Dosage FormsPh. Eur. 2.9.39 Dissolution of Patches and ImplantsPh. Eur. 2.9.4 Dissolution of Modified Release Dosage FormsPh. Eur. 2.9.40 Dissolution Testing for Oral SuspensionsPh. Eur. 2.9.43 In Vitro Dissolution Testing of Inhaled ProductsPh. Int. 2.9.5 Disintegration Testing of SuppositoriesUSP <1002> Dissolution Testing for Powder-Filled CapsulesUSP <1004> Disintegration Testing of Vaginal TabletsUSP <1087> Assessment of Drug Release from Extended Release TabletsUSP <1088> In Vitro Dissolution Profile Comparison for Generic DrugsUSP <1090> Assessment of Drug Release from Liposomal Dosage FormsUSP <1091> Assessment of Drug Release from MicrospheresUSP <1092> Dissolution Procedure Development and ValidationUSP <1094> Capsules—Dissolution and DisintegrationUSP <1097> Dissolution Testing for Transmucosal Drug Delivery SystemsUSP <2040> Dissolution Testing for Dietary SupplementsUSP <2041> Dissolution Testing of Oral Disintegrating TabletsUSP <2042> Disintegration and Dissolution of Buccal TabletsUSP <2043> Disintegration Testing of Chewable TabletsUSP <2044> Disintegration Testing for Orally Disintegrating TabletsUSP <2045> Dissolution of Transdermal PatchesUSP <2046> Disintegration of Medicated LozengesUSP <2047> Dissolution for Vaginal RingsUSP <2048> Dissolution for Oral Thin FilmsUSP <2049> Disintegration of Drug-Eluting StentsUSP <2050> Dissolution of Topical Creams and GelsUSP <2051> Dissolution Testing for Ion Exchange Resin-Based FormulationsUSP <2052> Disintegration of Controlled-Release TabletsUSP <2053> Dissolution Testing for Suppositories and PessariesUSP <2054> Disintegration Test for Extended-Release Film-Coated TabletsUSP <2055> Dissolution of Chewable GumsUSP <2056> In Vitro Drug Release for Implantable DevicesUSP <2057> Dissolution for Combination Drug ProductsUSP <2058> Dissolution for Oral Pellets and GranulesUSP <2059> Disintegration Testing of Oral Dispersible FilmsUSP <2060> In Vitro Release of Drug from Polymeric MicrospheresUSP <2061> Dissolution Testing of Nanocrystal FormulationsUSP <2062> Disintegration Testing for Multi-Layer TabletsUSP <2063> In Vitro Release Testing of Injectable SuspensionsUSP <2064> Dissolution of Non-Oral Dosage FormsUSP <2065> Disintegration Testing for Delayed Release CapsulesUSP <2066> Dissolution for MinitabletsUSP <2067> Dissolution of Coated Granules in SachetsUSP <2068> In Vitro Drug Release from Dermal SystemsUSP <2069> Disintegration Testing for Mucosal FilmsUSP <2070> Dissolution Testing for Sublingual TabletsUSP <2071> Drug Release Testing for Injectable GelsUSP <2072> Disintegration for Veterinary Bolus TabletsUSP <2074> Disintegration Testing of Gastro-Retentive TabletsUSP <2075> Dissolution Testing for Microemulsion SystemsUSP <2076> Dissolution Testing for Oral JelliesUSP <2077> Disintegration Testing for Modified-Release CapsulesUSP <2078> Dissolution of Floating TabletsUSP <2079> Disintegration Test for Multi-Unit Pellet SystemsUSP <2080> Drug Release from Drug-Eluting CoilsUSP <2081> In Vitro Drug Release Testing for Smart TabletsUSP <2082> Dissolution Testing of Effervescent GranulesUSP <2083> Disintegration Testing for Bilayer TabletsUSP <2084> Dissolution of Mucoadhesive TabletsUSP <2085> Disintegration of Matrix-Formed TabletsUSP <2086> Dissolution Testing of Suspended APIs in Liquid MediumUSP <2087> Disintegration Test for pH-Dependent Release CapsulesUSP <701> Disintegration of Effervescent TabletsUSP <701> Disintegration Testing of Uncoated TabletsUSP <705> Quality Attributes for Powder for Oral SuspensionUSP <711> Dissolution Testing of Immediate Release TabletsWHO Technical Report Series 929 Annex 9—Dissolution Testing for Quality Control

USP <2073> Dissolution of Multi-Compartment Capsules Laboratory Testing Service

Provided by Eurolab: A Complete Guide to Understanding the Standards, Requirements, Test Conditions, Methodology, Reporting, and Benefits

As a leading laboratory testing service provider, Eurolab is committed to delivering high-quality services that meet the stringent requirements of regulatory bodies, industries, and customers. One such critical testing service is the USP <2073> Dissolution of Multi-Compartment Capsules test. This comprehensive guide provides an in-depth understanding of the standards, requirements, test conditions, methodology, reporting, and benefits associated with this laboratory testing service.

The USP <2073> Dissolution of Multi-Compartment Capsules test is governed by several international and national standards, including:

  • USP 2073: This standard specifies the requirements for dissolution testing of multi-compartment capsules.

  • ISO 12393-1: This standard provides general guidance on dissolution testing of solid oral dosage forms.

  • ASTM E2872: This standard outlines the test method for dissolution of solid oral dosage forms.

  • EN ISO 14534: This European standard specifies the requirements for dissolution testing of solid oral dosage forms.

    • The legal and regulatory framework surrounding this testing service is primarily driven by regulatory bodies such as:

  • US FDA: The US Food and Drug Administration enforces the standards and regulations related to dissolution testing in the United States.

  • EMA: The European Medicines Agency oversees the implementation of EU regulations, including those related to dissolution testing.

  • WHO: The World Health Organization provides international guidelines for pharmaceutical products, including dissolution testing.

    • The international and national standards that apply to this specific laboratory test are:

  • USP <2073> Dissolution of Multi-Compartment Capsules: This standard specifies the requirements for dissolution testing of multi-compartment capsules.

  • ISO 12393-1:2014: General guidance on dissolution testing of solid oral dosage forms.

  • ASTM E2872:2020: Test method for dissolution of solid oral dosage forms.

    • Standard development organizations, such as:

  • USP: United States Pharmacopeia

  • ISO: International Organization for Standardization

  • ASTM: American Society for Testing and Materials

    • play a crucial role in developing and updating standards related to dissolution testing. Standards evolve over time due to advances in technology, changes in regulations, or new scientific discoveries.

    The standard numbers and their scope are:

    Standard Number Title

    --- ---

    USP <2073> Dissolution of Multi-Compartment Capsules

    ISO 12393-1:2014 General guidance on dissolution testing of solid oral dosage forms

    ASTM E2872:2020 Test method for dissolution of solid oral dosage forms

    Compliance with these standards is mandatory for pharmaceutical manufacturers, and failure to do so can result in regulatory actions, product recalls, or even business closure.

    The USP <2073> Dissolution of Multi-Compartment Capsules test is essential due to:

  • Business and Technical Reasons: Pharmaceutical manufacturers must ensure that their products meet the required dissolution standards to comply with regulations, maintain product quality, and reduce costs.

  • Consequences of Non-Compliance: Failure to perform this test can lead to regulatory actions, product recalls, or even business closure.

    • The industries and sectors that require this testing are:

  • Pharmaceutical Industry

  • Biotechnology Industry

  • Cosmetics Industry

    • The risk factors and safety implications associated with non-compliant products include:

  • Patient Safety: Non-compliant products can lead to reduced efficacy, adverse reactions, or even death.

  • Product Liability: Manufacturers may face lawsuits, recalls, and financial losses due to non-compliance.

    • Quality assurance and quality control aspects are critical in ensuring the accuracy and reliability of test results. This includes:

  • Calibration and Validation: Equipment must be calibrated regularly, and validation procedures must be followed to ensure accurate results.

  • Sample Preparation: Samples must be prepared according to standard protocols to ensure representative results.

  • Measurement and Analysis Methods: Standardized measurement and analysis methods must be used to ensure consistent results.

    • The USP <2073> Dissolution of Multi-Compartment Capsules test involves the following steps:

    1. Sample Preparation: Samples are prepared according to standard protocols, including weighing, mixing, and loading.

    2. Equipment Setup: The dissolution apparatus is set up according to manufacturers instructions and standards.

    3. Test Conditions: The test conditions, including temperature, pH, and agitation rate, must be controlled and maintained within specified limits.

    4. Measurement and Analysis Methods: Standardized measurement and analysis methods are used to determine the dissolved substance concentration.

    The dissolution apparatus is calibrated regularly to ensure accurate results. The equipment setup includes:

  • Dissolution Apparatus: USP <2073> recommends the use of a rotating basket or paddle dissolution apparatus.

  • Temperature Control System: A temperature control system must be used to maintain the test temperature within 1C.

    • The test report should include:

  • Sample Identification: The sample identification, including name, batch number, and date of analysis.

  • Test Conditions: A detailed description of the test conditions, including temperature, pH, and agitation rate.

  • Measurement and Analysis Methods: A description of the measurement and analysis methods used to determine the dissolved substance concentration.

  • Results: A summary of the test results, including mean dissolution values and standard deviations.

    • The benefits associated with the USP <2073> Dissolution of Multi-Compartment Capsules test include:

  • Improved Product Quality: Compliance with standards ensures that products meet regulatory requirements and maintain quality.

  • Reduced Costs: Compliance reduces costs associated with non-compliance, such as product recalls, lawsuits, and financial losses.

  • Enhanced Patient Safety: Compliance ensures that patients receive safe and effective products.

    • In conclusion, the USP <2073> Dissolution of Multi-Compartment Capsules test is a critical laboratory testing service that ensures compliance with regulatory standards, maintains product quality, and reduces costs. Eurolab is committed to delivering high-quality services that meet the stringent requirements of regulatory bodies, industries, and customers.

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